Product Surveillance Registry (NCT01524276)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (4 items).
Location: Clinical Research Facility — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient who is, or will be, inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (400 Sites)
- Clinical Research Facility — Birmingham, Alabama
- Clinical Research Facility — Huntsville, Alabama
- Clinical Research Facility — Chandler, Arizona
- Clinical Research Facility — Phoenix, Arizona
- Clinical Research Facility — Little Rock, Arkansas
- Clinical Research Facility — Aliso Viejo, California
- Clinical Research Facility — Chula Vista, California
- Clinical Research Facility — Colton, California
- Clinical Research Facility — La Jolla, California
- Clinical Research Facility — Los Angeles, California
- Clinical Research Facility — Napa, California
- Clinical Research Facility — Redwood City, California
- Clinical Research Facility — Salinas, California
- Clinical Research Facility — San Diego, California
- Clinical Research Facility — Stanford, California
- Clinical Research Facility — Torrance, California
- Clinical Research Facility — Ventura, California
- Clinical Research Facility — Aurora, Colorado
- Clinical Research Facility — Colorado Springs, Colorado
- Clinical Research Facility — Lakewood, Colorado
- Clinical Research Facility — Darien, Connecticut
- Clinical Research Facility — Hartford, Connecticut
- Clinical Research Facility — New Haven, Connecticut
- Clinical Research Facility — Washington D.C., District of Columbia
- Clinical Research Facility — Bradenton, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.